PbIn a few words /b /ppbr/ppPosition: QA Techinician. /ppLocation: León. /ppExperience: Between 1-3 years. /ppbr/ppbr/ppbWant to know more? /b /ppbr/ppINSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health. /ppbr/ppThe activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized RD centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. /ppbr/ppbr/ppbr/ppbThe challenge: /b /ppbr/ppPrepare and review release specifications, shelf life requirements and customer requests; revision of master batch records and its validation/compliance on SAP system (BOM/Route); manage GMP deviations relative to the site; review and approval manufactured and packaged batches and related analytical data, including OOS if any, previous to put them on the market; revision and sign the certificate of analysis; periodic stock control check; manage of not conformities form for packaging materials according to European standards and quality policy All this taking into account the safety regulations indicated by the company and the use of personal protective equipment provided depending on the risks of each operation.others. /ppbr/ppbr/ppbSpecific Responsibilities: /b /ppbr/pulliRevision and approval of the API, raw materials, packaging components, bulk and finish product release specifications. /liliReview and approval of the bulk and packaged batch records and related documents. /liliReview and approval of the analytical data related to the industrial products and/or components according to the internal SOPs, including OOS, OOT and deviations. /liliIssue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes on different countries to be marketed. /liliIssue and approve certificate of analysis related to raw materials. /liliApprove and/or reject batches of product (bulk and finished), raw materials and packaging materials in SAP system. /liliMonitoring deviations/OOS/OOT reports raised on batches for approval. /liliReview, maintain and approve all master batch records and its status on SAP system according to the marketing authorization. /liliManagement of GMP documentations and related archive. /liliTrain the new incorporations in the specific activities and functions of the position in which you are an expert. /li /ulpbr/ppbr/ppbRequirements and personal skills: /b /ppbr/pullibEducation: /b University Degree in Pharmacy, Chemistry, Biology or Sciences related to Health. /lilibLanguages: /bIntermediate or high level of English and bilingual in Spanish. /lilibExperience (years/area): /b A minimum of 3 years’ experience in similar position for a senior position. /lilibSpecific Knowledge: /bQuality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on SAP/R3 and MS Office system. /lilibTravels: /b Willing to travel occasionally. /lilibPersonal skills: /bGood communication skills, proactivity, good working under pressure, team working, problem-solving, good organizational skills and persistent. /li /ulpbr/ppbr/ppbr/ppbCOMMITMENT TO EQUAL OPPORTUNITIES /b /ppbr/ppThe InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance. /p